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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)
Classification Namepulse generator, permanent, implantable
Generic Nametranstelephonic follow-up/monitoring system
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP910023
Supplement NumberS098
Date Received02/02/2006
Decision Date04/05/2006
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor modifications to the design of the high voltage capacitor, battery, feedthrus/headers and discrete components. Specifically, alteration of the battery pin configuration, modification of the feedthru wire tubing lengths and of the method used for applying insulation, change in the value of c36 capacitor from 10nf to 680pf, qualification of an alternate accelerometer substrate with integrated resistor capacitor, and the shifting of the anchor bridge to feedthru flange from 0. 17" to 0. 18".
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